Replimune reported strong initial engagement from healthcare providers for TUDRIQEV's launch and affirmed its fiscal 2027 financial outlook, following FDA clearance for the oncolytic immunotherapy.
REPL news
Latest 8 stories · newest Oct 28, 2026
Replimune Group Inc. has entered into an underwriting agreement to sell an aggregate of 9,701,490 shares of common stock and pre-funded warrants for 2,736,340 additional shares. The offering is led by Leerink Partners LLC and J.P. Morgan Securities LLC, and could potentially increase the company's e…
Repligen CEO Olivier Loeillot highlights Bio-Life's industry leadership and outlines the integration of their cell processing operations, targeting a fourth-quarter closing.
RP1's IGNYTE study efficacy results were deemed evaluable and clinically meaningful by the FDA's Cell, Tissue, and Gene Therapies Advisory Committee. The favorable outcome is a key regulatory milestone as the company awaits an August 2 action date.
Replimune announced fiscal 2026 financial results and confirmed the FDA accepted its resubmission of the BLA for RP1 in combination with nivolumab for advanced melanoma with a goal date set for August 2026. This regulatory milestone, combined with strong clinical data presentations, supports the com…
Replimune announced it will resubmit its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma following productive FDA discussions, with the agency committing to prioritize review. The development signals regulatory progress for the company's lead oncolytic immun…
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